42
14. Time constant: ≥ 3.2s for enhance mode ≥ 0.3s for normal mode.
15. Frequency response: 0.05Hz~40 Hz for enhance mode 0.5Hz~40Hz for normal mode.
6.2 TEMP Monitoring
1. TEMP measuring range: 21.0°C~50.0°C.
2. TEMP measuring accuracy: not greater than 0.2°C for TEMP measuring range from 25.0°C~45.0°C.
3. TEMP responding time: ≤150s for KRK sensor; ≤40s for YSI sensor.
6.3 NIBP Monitoring
1. Measuring method: Oscillometric Technique.
2. Pneumatic pressure measuring range: 0 mmHg~300mmHg.
3. Accuracy of pressure measurement: ±3 mmHg.
4. Cuff inflation time: <10 seconds (typical adult cuff).
5. Average measurement time: < 90 seconds.
6. Air release time while the measurement is canceled: ≤2 seconds (typical adult cuff).
7. Initial cuff inflation pressure
Adult: 175 mmHg
Pediatric: 135 mmHg
Neonate: 65 mmHg
8. Overpressure protection limit
Adult: ≤ 300 mmHg
Pediatric: ≤ 240mmHg
Neonate: ≤ 150 mmHg
9. NIBP measurement range:
10. NIBP measurement accuracy:
Maximal mean difference: ±5 mmHg.
Maximal standard deviation: 8 mmHg.
Measurement mode: Manual, Auto, STAT.
6.4 SpO
2
Monitoring
1. Transducer: dual-wavelength LED.
Wavelength: Red light: 663 nm, Infrared light: 890 nm.
Maximal optical output power: less than 2mW maximum average.
2. SpO
2
measuring range: 35%~100%.
Additional declarations to conform the particular standard of IEC 60601-2-27 “Medical electrical
equipment – Part 2-27: Particular requirements for the safety, including essential performance, of
electrocardiographic monitoring equipment”
Direct current for respiration,
leads-off sensing, and active
noise suppression
Applied current less than 0.1 microamperes
Response to irregular rhythm A1 Ventricular bigeminy-80BPM
A2 Slow alternating ventricular bigeminy-60BPM
A3 Rapid alternating ventricular bigeminy-120BPM
A4 Bidirectional systoles-90BPM
Time to ALARM for
tachycardia
Waveform B1, Amplitude
0.5 mV
1 mV
2mV
Average Time to Alarm
<8 sec
<8 sec
<8 sec
Waveform B2, Amplitude
1mV
2mV
4mV
Average Time to Alarm
<8 sec
<8 sec
<8 sec
Press (unit)
Adult
Pediatric
Neonate
SYS
mmHg
40~275
40~200
40~135
MAP
mmHg
20~230
20~165
20~110
DIA
mmHg
10~210
10~150
10~95